a clinical study evaluaing the efficacy, safety, and patient satisfaction of injectable hylaronic acid with 0.3% lidocain hydrochloride, prevelle silk, for superficial, vertical perioral lines and superficial, horizontal, lateral canthal lines

Conditions: Wrinkles

Summary: statistical hypotheses the null hypothesis: there is no difference in the reduction of lines in the treated areas as compared to baseline. alternative hypothesis: there is a difference in the reduction of lines in the treated areas as compared to baseline.


Eligibility criteria:
inclusion criteria: * females and males in good general health between 35 to 65 years of age. * must be willing to give and sign a hippa form, informed consent form and a photographic release form * patient is planning to undergo prevelle silk treatment * a potential subject's must exhibit: a. moderate to severe superficial, vertical perioral and horizontal canthus lines * for female patient of childbearing potential, must have had a regular menstrual cycle prior to study entry (a female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation) and is willing to use an acceptable form of birth control during the entire course of the study \[i.e., acceptable methods of birth control are oral contraceptives, contraceptive patches/rings/implants norplanit®, depo-provena®, double-barrier methods (e.g. condoms and spermicide), abstinence and vasectomies of partner with a documented second acceptable method of birth control should the patient become sexually active\]. all systemic birth control measures must be in consistent use at least 30 days prior to study participation * negative urine pregnancy test results at the time of study entry (if applicable) * must be willing to comply with study regimen and complete the entire course of the study. exclusion criteria: * a patient with any uncontrolled systemic disease. a potential patient in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study * a patient with a significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study. * a patient with a known hypersensitivity to any of the components of the study medications * a patient who is actively smoking or plans to smoke at any time of the duration of this study * a patient with an active skin condition/disease that might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis, seborrheic dermatitis, herpes labialis) * a patient planning any other cosmetic procedure to their facial area during the study period, other than the treatments that will be performed by the investigator * a patient using any topical (prescription or over the counter) medicated creams, lotions, gels, balms, powders, etc. on the treatment areas during the study period * a patient receiving any topical products containing alpha-hydroxy acids, salicylic acid, and vitamins c or d (includes derivatives thereof) on the perioral or lateral canthal areas within 7 days prior to or during the study period, other than the study products * a patient receiving any investigational drug and/or has had a microdermabrasion (light or medium skin peel) treatment on their perioral or lateral canthal areas within 30 days prior to or during the study period * a patient using any topical tretinoin product or derivative on their perioral or lateral canthal areas within 12 weeks prior to or during the study period * a patient receiving a chemical peel, any systemic steroids, a non-ablative laser, light or radio frequency treatment and/or has had a dermabrasion (deep skin peel) or ablative laser treatments on their perioral or lateral canthal areas must have discontinued the drug/treatment and/or had the procedure at least 6 months prior to entering the study * a patient that has previously been treated with botulinum toxin in the perioral or lateral canthal areas within the past six months * a patient that has previously been treated with dermal filler in the perioral or lateral canthal areas within the past year * a patient that with a history of allergic reaction to a dermal filler or lidocaine * a patient that with a history of a permanent filler to the perioral or lateral canthal areas * a female patient who is pregnant, nursing an infant or planning a pregnancy during the study \[throughout the course of the study, women of child-bearing potential must use reliable forms of contraception (i.e., oral contraceptive, intrauterine device, abstinence, or spermicides and condoms used in combination)\] * current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.

Keywords: superficial vertical perioral lines superficial horizontal and lateral canthal lines correct moderate to severe facial wrinkles and folds